Local response rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Responses will be assessed at week 5 and week 15 of the trial by PET/CT. Tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). Criteria as described by the European Organisation for Research and Treatment of Cancer (EORTC) PET study group will be used to assess response based on standard uptake value (SUV).

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Fresolimumab and Radiotherapy in Metastatic Breast Cancer

Official Title ICMJE

Fresolimumab and Radiotherapy in Metastatic Breast Cancer

Brief Summary

The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.

Hepatic: Serum total bilirubin ≤1.5x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if total bilirubin is ≤3.0mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2.5xULN. If patient has known liver metastases, ALT and/or AST ≤5xULN are allowed.

Renal: creatinine clearance ≥60mL/min.

Prothrombin (PT) and partial thromboplastin times (PTT) <ULN.

Negative for hepatitis viruses B and C unless consistent with prior vaccination or prior infection with full recovery.

Patients of childbearing potential must agree to use effective contraception while on study, and for ≥3 months after last treatment.

Understand and sign written informed consent document. No consent by durable power of attorney.

Exclusion Criteria:

Second malignancy - unless following curative intent therapy, has been disease free for ≥2 years with probability of recurrence <5%. Curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are allowed.

Systemic corticosteroid therapy, including replacement therapy for hypoadrenalism. Inhaled or topical corticosteroids are allowed (if therapy is <5 days and is limited to systemic steroids as antiemetics);

Cyclosporine A, tacrolimus, or sirolimus.

Investigational agents within 4 weeks prior to study enrollment (≥6 weeks if treatment was long-acting agent such as monoclonal antibody).